Device Classification Name |
Electrode, Cutaneous
|
510(k) Number |
K112312 |
Device Name |
THERATRODE |
Applicant |
PHOENIX MEDICAL DEVICES, LLP |
2458 ALTON PARKWAY |
IRVINE,
CA
92606
|
|
Applicant Contact |
JIM KLETT |
Correspondent |
PHOENIX MEDICAL DEVICES, LLP |
2458 ALTON PARKWAY |
IRVINE,
CA
92606
|
|
Correspondent Contact |
JIM KLETT |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 08/11/2011 |
Decision Date | 01/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|